FDA Events for Polyrizon (PLRZ)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Polyrizon (PLRZ).
Over the past two years, Polyrizon has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PL-14. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PL-14 - FDA Regulatory Timeline and Events
PL-14 is a drug developed by Polyrizon for the following indication: For seasonal allergic rhinitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PL-14
- Announced Date:
- April 25, 2025
- Indication:
- For seasonal allergic rhinitis.
Announcement
Polyrizon Ltd.announced the successful preliminary safety study for a formulation of its PL-14 Allergy Blocker, marking a significant advancement in the product's development path.
AI Summary
Polyrizon Ltd., an Israeli biotech company, announced a successful preliminary safety study for its PL-14 Allergy Blocker formulation. The study, conducted using a human nasal tissue model (MucilAir™), tested the nasal gel spray that is designed to form a physical barrier against airborne allergens. Researchers evaluated key safety indicators such as tissue integrity, cytotoxicity, cilia beating frequency, mucociliary clearance, and inflammatory response during a 4‑hour application period. The results showed strong local tolerability with no tissue damage or inflammation detected, marking an important milestone in the product’s development path.
This advancement supports Polyrizon’s goal of developing a drug-free nasal spray for daily protection against allergens. The positive results also lay the foundation for future clinical trials and further regulatory discussions as the company moves closer to bringing PL-14 Allergy Blocker to market.
Read Announcement- Drug:
- PL-14
- Announced Date:
- March 27, 2025
- Indication:
- For seasonal allergic rhinitis.
Announcement
Polyrizon Ltd announced the structuring of its clinical strategy for PL-14, the Company's proprietary intranasal allergy blocker for seasonal allergic rhinitis.
AI Summary
Polyrizon Ltd has structured its clinical strategy for PL-14, an innovative intranasal allergy blocker designed to treat seasonal allergic rhinitis. The company plans to conduct a series of clinical studies to gather key data on the product’s efficacy, safety, user experience, and nasal residence time. One study will evaluate the effectiveness of PL-14 during peak allergy season under natural conditions, while another will focus on human factors to assess usability and patient acceptance. An additional study will examine how long the formulation remains in the nasal cavity. Tomer Izraeli, CEO of Polyrizon, remarked that the updated plan is an important step toward regulatory approval and eventual commercialization. The company aims to begin clinical trials in the United States and Europe by late 2025 or early 2026, following completion of preclinical work and further regulatory consultations.
Read Announcement
Polyrizon FDA Events - Frequently Asked Questions
As of now, Polyrizon (PLRZ) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Polyrizon (PLRZ) has reported FDA regulatory activity for PL-14.
The most recent FDA-related event for Polyrizon occurred on April 25, 2025, involving PL-14. The update was categorized as "Provided Update," with the company reporting: "Polyrizon Ltd.announced the successful preliminary safety study for a formulation of its PL-14 Allergy Blocker, marking a significant advancement in the product's development path."
Currently, Polyrizon has one therapy (PL-14) targeting the following condition: For seasonal allergic rhinitis..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:PLRZ) was last updated on 7/14/2025 by MarketBeat.com Staff